Masimo (NSDQ:MASI) announced today that it received FDA clearance for its SedLine monitoring and SedLine pediatric EEG sensor.
Clearance covers Sedline brain functioning monitoring for pediatric patients (between one and 17 years of age), along with the pediatric EEG sensor.
Irvine, California-based Masimo said in a news release that the clearance expands SedLine’s benefits to all patients aged one and up in the U.S. as it allows clinicians to monitor brain activity bilaterally with the company’s advanced signal processing technology. The platform processes electroencephalogram (EEG) signals from the four-lead SedLine EEG sensors.
The clearance allows for Masimo’s bilateral brain activity monitoring to be used in children in conjunction with specially sized pediatric sensors designed for easier application on smaller foreheads.
Masimo said that maintaining an appropriate depth of anesthesia is key to preventing anesthesia-related events and enabling faster recovery, so SedLine features the display of EEG signals nad the multitaper density spectral array (DSA) from both sides of the brain to offer a more complete picture and help clinicians monitor anesthesia depth for children.
“SedLine is achieving for brain function monitoring what Masimo SET did for pulse oximetry,” Masimo Founder and CEO Joe Kiani said in the release. “We believe SedLine is the best and most advanced way to monitor depth of sedation, crucial to helping ensure patients with even the most challenging and the youngest brains are appropriately anesthetized. We are proud to be able to bring its benefits to children in the United States.”